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The SBIR and STTR Programs at the National Institutes of Health

The SBIR and STTR Programs at the National Institutes of Health. General Information and Nuances. Agenda. Basics of the SBIR & STTR programs NIH SBIR/STTR programs Overview What’s new Latest funding opportunities University participation/involvement. $$$$$. Program Descriptions.

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The SBIR and STTR Programs at the National Institutes of Health

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  1. The SBIR and STTR Programs at the National Institutes of Health General Information and Nuances

  2. Agenda • Basics of the SBIR & STTR programs • NIH SBIR/STTR programs • Overview • What’s new • Latest funding opportunities • University participation/involvement $$$$$

  3. Program Descriptions • Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. • Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. 2.5% 0.3%

  4. SBIR/STTR: 3-Phase Program PHASE I • Feasibility Study • $100K and 6-month (SBIR) or 12-month (STTR) Award PHASE II • Full Research/R&D • $750K and 2-year Award (SBIR/STTR) PHASE III • Commercialization Stage • Use of non-SBIR/STTR Funds

  5. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • Research Partner SBIR:Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR:Requiresresearch institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] AWARD ALWAYS MADE TO SMALL BUSINESS

  6. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern*] *Varies Among Agencies

  7. SBIR PROGRAM ELIGIBILITY CHECKPOINTS • Organized for- profit U.S. business • At least 51% U.S.- owned and independently operated • Small Business located in the U.S. • 500 or fewer employees • P.I.’s primary employment with small businessduring project

  8. STTR PROGRAM ELIGIBILITY CHECKPOINTS • Applicantis Small Business Concern • Formal Cooperative R&D Effort • Minimum 40% by small business • Minimum 30% by U.S. research institution • U.S. Research Institution • College or University; other non-profit research organization; Federal R&D center • Intellectual Property Agreement • Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization

  9. TOTAL ~ $2.0 B Est. FY 2004 SBIR / STTR Participating Agencies • DOD SBIR/STTR • HHS SBIR/STTR • NASA SBIR/STTR • DOE SBIR/STTR • NSF SBIR/STTR • DHS SBIR • USDA SBIR • DOC SBIR • ED SBIR • EPA SBIR • DOT SBIR New

  10. We’re all just a little bit different ...

  11. Agency SBIR Differences • Number and Timing of Solicitations • R&D Topic Areas -- (Broad vs. Focused) • Dollar Amount of Award (Phase I and II) • Proposal Preparation Instructions • Financial details (e.g., Indirect Cost Rates, Gap Funding) • Receipt Dates • Proposal Review Process • Proposal Success Rates • Type of Award (Contract or Grant)

  12. Agency SBIR Differences Contracting Agencies • Agency establishes plans, protocols, requirements • Highly focused topics • Procurement mechanism for DOD and NASA • More fiscal requirements Granting Agencies • Investigator initiates approach • Less-specified topics • Assistance mechanism • More flexibility DOD HHS/NIH NASA ED EPA DOT DOC HHS/NIH NSF ED USDA DOE

  13. NIH Mission IMPROVE HUMAN HEALTH through biomedical and behavioral research, research training and communications.

  14. Small Companies Can Help NIH meet its mission Conduct innovative R/R&D that results in product, process, or service that will... • Improve patient health • Speed process of discovery • Reduce cost of medical care/cost of research • Improve research & communication tools

  15. SBIR/STTR Participating Agencies TOTAL ~ $2.0 B FY 2004 NIH: $ 564 M SBIR $ 67 M STTR $631 M Total CDC: $ 8.0 M SBIR FDA: ~ $ 0.8 M SBIR AHRQ: ~$ 2.1 M SBIR • DOD SBIR/STTR • NASA SBIR/STTR • DOE SBIR/STTR • NSF SBIR/STTR • DHS SBIR • USDA SBIR • DOC SBIR • ED SBIR • EPA SBIR • DOT SBIR • HHS SBIR/STTR

  16. NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2003 327 18 $563 M SBIR/STTR (set aside $556M) 44% 43% 5 95 981 61 28% Success Rate (%) 27% 24% 22%

  17. NUANCES NIH SBIR & STTR Programs • SBIR and STTR Program • Multiple Award Mechanisms • Multiple Receipt Date • Budget ~$100K/ $750K • External Peer Review Critiques sent to all applicants • Phase III • Single Solicitation • ~ 95% Awards are grants • April 1, Aug 1, Dec 1 • Realistic & appropriate • Academia and industry • NIH: rarely your customer

  18. Examples of Cross-Cutting Areas of Interest • Nanotechnologies • Bioinformatics • Biodefense • Proteomics / Genomics • Genetically engineered proteins • Biosensors • Biosilicon devices • Biocompatible materials • Acousto-optics and opto-electronics • Imaging technologies • Education/communication tools • Computational biology • Behavioral research

  19. Our Ideas … • SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA)Release: January Open for entire Calendar Year • SBIR Contract Solicitation (NIH, CDC) Release: August Open for ~ 3 months • NIH Guide for Grants and Contracts • Release: Weekly Open as noted

  20. Your Ideas … • Investigator-initiated R&D • Research projects related to the NIH mission • “Other” areas of research within the mission of an awarding component

  21. SBIR/STTR Award Type • Multiple Mechanisms GRANTS, Contracts, Cooperative Agreements • Award Amount and Project Period • Phase I ~$100,000 6 months • Phase II ~$750,000 2 years Realistic and appropriate

  22. Center for Scientific ReviewReceipt & Referral Office Application Assignments Institutes/Centers Scientific Review Group Match between proposed research and review groups for scientific/technical merit Match between proposed research and IC’s mission for funding

  23. NIH Center for Scientific Review Assign to IC and IRG Small Business Concern Applicant Initiates Research Idea Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds NIH SBIR/STTR PROGRAM Review Process for Research Grant Submits SBIR/STTR Grant Application to NIH ~2-3 months after submission ~2-3 months after review IC Staff Prepare funding Plan for IC Director Grantee Conducts Research

  24. APPLICATION, REVIEW, and AWARD TIMELINE SBIR/STTR Scientific/Technical Adv Council Awd Receipt Dates Peer Review Board Review Date Apr 1 June/July Sept/Oct Nov Aug 1 Oct/Nov Jan/Feb Mar Dec 1 Feb/March May/June July 7 to 9 months 90-Day pre-award costs are allowable: At your own risk…..

  25. REVIEW CRITERIA (Phase I) • Significance (Real Problem/Real People) • Approach (Research Design, Feasible) • Innovation (New or Improved?) • Investigators (PI and team) • Environment (Facilities/Resources) … Protection of Human Subjects … Animal Welfare … Budget

  26. Phase II Review Criteria • Same as Phase I • Demonstrated Feasibility in Phase I • Commercialization Plan • High Degree of Commercial Potential based on plan … Protection of Human Subjects … Animal Welfare … Budget

  27. 7-9 months 7-9 months Phase I Phase II 6 months 6 months 24 months Satisfactory Phase I Final Report 7-9 months Phase I + Phase II Simultaneous submission/review Phase II SBIR “FAST-TRACK” Standard application, review, award process Fast-Track review option

  28. No! NIH SBIR “FAST-TRACK”Best Option For Everyone? • Convincing preliminary data? • Clear, measurable, achievable milestones? • Well-conceivedCommercialization Plan? • Letters of Phase III support/interest? • Track record for commercializing? Speak with Program Staff Prior to Submission

  29. What’s New? • Phase II Competing Continuations • Technical Assistance Programs • Executive Order 13329 – Encouraging Innovation in Manufacturing

  30. Phase II Competing Continuations • Goal: Provide additional research funds to move already identified drugs or devices requiring regulatory approval into clinical trials • Stipulations: • Available only to Phase II grantees preparing for clinical trials • Focus -- Diagnostics, devices, tissue engineering, drug development • Funding level: $750K to $1M per year for maximum of 3 years • IC must have announced the opportunity Speak with Program Staff Prior to Submission

  31. Phase II Competing Continuations • Omnibus • Solicitation • NIA • NIDCD • NINDS • PAs & RFAs • NIMHPA-01-173 • NICHD PA-03-085 • NCI PA-04-047 • NIAAA PA-03-129 • NHLBI PA-04-028 • NIAID RFA-AI-04-005 • NIDA PA-03-154

  32. Technical Assistance Programs Business & strategic planning Builds alliances and investor partnerships Commercialization Assistance (Phase II awardees) Identify other uses of technology Determines competitive advantages Develops market entry strategy Pilot Niche Assessment (Phase I awardees)

  33. Executive Order 13329 Requires SBIR/STTR Agencies to give high priority to manufacturing-related research and development …relating to manufacturing processes, equipment and systems; or manufacturing workforce skills and protection

  34. Latest Funding Opportunities (Samples)http://grants.nih.gov/grants/funding/sbir_announcements.htm • RFA-CA-05-006: Innovative Technologies for Molecular Analysis of Cancer (SBIR/STTR) • PAR-03-119: Innovations in Biomedical Computational Science and Technology • PA-04-094: Novel Technologies for In Vivo Imaging

  35. RFA-CA-05-006: Innovative Technologies for Molecular Analysis of Cancer Objective: To develop highly innovative cancer-related methods and tools that enable research Unique Features: • Special receipt dates (Mar, Jun, Oct) • Initial review convened by NCI • Parallel in scope with RFA-CA-05-002 • Flexible budget and project durations Phase I: 2 yrs, $100K direct costs each year Phase II: 3 yrs, no official budget limit • Annual meeting of investigators

  36. PAS-02-149: Small Business Biodefense Program Objective:To rapidly develop specific products for biodefense Unique Features: • ~ $35M “set-aside” in FY 2003 • Flexible budget and project durations Phase I: 2 yrs, $500K total costs per year Phase II: 3 yrs, $2M total costs per year • Mandatory milestone – approval of the final clinical protocol by NIAID prior to start of clinical trial

  37. University Partnerships(Provide analytical and other service support) • Consultants on SBIR/STTR • Subcontracts on SBIR/STTR • Senior Personnel on SBIR/STTR • Principal Investigator (with official permission from University) • Own small firms (assign someone else PI) Applicant must be the small business!

  38. http://grants.nih.gov/grants/funding/sbir.htm • Alerts • Solicitations • Targeted Research Opportunities • Sample Application • Award Information • Collaborative Opportunities • Success Stories

  39. I’m from the Government, and I’m here to help you….

  40. Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Fax: 301-480-0146 Email: goodnigj@od.nih.gov Kay Etzler SBIR/STTR Program Phone: 301-435-2713 Fax: 301-480-0146 Email: etzlerk@od.nih.gov

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